CC-10004-PSA-005 Apremilast in Active Psoriatic Arthritis

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of two doses of Apremilast (CC-10004) in Subjects with Active Psoriatic Arthritis who have not been previously treated with Disease-Modifying Antirheumatic Drugs

• IRAS ID

  69675

• Contact name

  Adewale Adebajo

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2010-020324-22

• ISRCTN Number

  n/a

• Research summary

  Psoriatic arthritis (PsA) is an inflammatory arthritis (associated with swelling and pain) that occurs in 6-39% of patients with psoriasis. It is a chronic disorder with worsening joint inflammation and destruction over time. Current treatment for milder PsA often involves nonsteroidal anti-inflammatory drugs and injections of corticosteroids. For patients with more severe disease, standard of care is disease modifying anti-rheumatic drugs (such as methotrexate), given before irreversible joint damage occurs. However, these drugs have only shown mild efficacy. The ability to control disease has been improved by TNF blockers but a large number of patients fail to obtain satisfactory response and use of these agents is limited by risks of harmful effects. PsA requires long-term treatment over decades, ideally with effective agents that offer convenient dosing and a low incidence of side effects. Apremilast works by altering the levels of chemicals in the body that cause swelling and therefore improves PsA symptoms (such as joint pain, redness and swelling). The purpose of this study is to assess the efficacy of two doses of apremilast (20mg or 30mg twice daily) compared to placebo (dummy drug). Participants will receive placebo, 20mg or 30mg apremilast by mouth twice daily for the first 24 weeks. Some participants will switch from placebo to apremilast after 16 weeks of treatment, and all participants will be switched to apremilast after 24 weeks. Participants will remain in the study for up to 112 weeks (4-week Screening Phase, 24-week Placebo-controlled Phase, 80-week Active Treatment/ Long-term Safety Phase and 4-week Observational Follow-up Phase). Participants will visit the hospital regularly and the following procedures will be performed: physical examinations, questionnaires, blood tests and ECGs. This study is sponsored by Celgene Corporation. Approximately 495 patients will participate in this study worldwide with 25 patients from 5 hospitals in the UK.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  11/H1306/1

• Date of REC Opinion

  7 Mar 2011

• REC opinion

  Further Information Favourable Opinion